Use of the WHO Certification Scheme on the Quality of Pharmaceutical Products Moving in International Commerce - EDM Research Series No. 016
(1995; 156 pages) Voir le document au format PDF
Table des matières
Afficher le documentACKNOWLEDGMENTS
Afficher le documentPREFACE
Afficher le documentEXECUTIVE SUMMARY
Ouvrir ce répertoire et afficher son contenu1. INTRODUCTION
Afficher le document2. RATIONALE AND OBJECTIVE OF THE ASSESSMENT
Afficher le document3. ACTIVITIES UNDERTAKEN: Preparations and Method of Work
Ouvrir ce répertoire et afficher son contenu4. ANALYSIS OF RESULTS FROM IMPORTING COUNTRIES
Ouvrir ce répertoire et afficher son contenu5. ANALYSIS OF RESULTS FROM EXPORTING COUNTRIES
Afficher le document6. ANALYSIS OF RESULTS FROM INTERNATIONAL SUPPLY AGENCIES
Ouvrir ce répertoire et afficher son contenu7. SUMMARY ANALYSIS
Afficher le document8. CONCLUSIONS
Afficher le documentANNEX 1: Resolution adopted by the Twenty-second World Health Assembly
Afficher le documentANNEX 2 (a): Resolution Adopted by the Twenty-Eighth World Health Assembly
Afficher le documentANNEX 2 (b): Certificate of Pharmaceutical Product(S)1
Afficher le documentANNEX 3 (a): Resolution adopted by the Forty-first World Health Assembly
Afficher le documentANNEX 3 (b): Certificate of Pharmaceutical Product(s)1 (Proposed Layout)
Afficher le documentANNEX 4 (a): Proposed Guidelines on the WHO Certification Scheme on the Quality of Pharmaceutical Products Moving in International Commerce
Afficher le documentANNEX 4 (b): Certificate of a Pharmaceutical Product
Afficher le documentANNEX 4 (c): Statement of Licensing Status of Pharmaceutical Product(s) Model Statement of Licensing Status of Pharmaceutical Product(s)
Afficher le documentANNEX 4 (d): Manufacturer’s/Official Batch Certificate of a Pharmaceutical Product
Afficher le documentANNEX 5: Protocol for the Assessment of the Use of the WHO Certification Scheme by Importing Country
Afficher le documentANNEX 6: List of Participants in the Study
Afficher le documentANNEX 7: Protocol for the Assessment of the Use of the WHO Certification Scheme by Exporting Country
Afficher le documentANNEX 8: Protocol for the Assessment of the Use of the WHO Certification Scheme in an International Supply Organization
Afficher le documentANNEX 9: Study Instrument for Assessment of the WHO Certification Scheme by Importing Country
Fermer ce répertoireANNEX 10: Summaries of Mission Reports on the Assessment of the Use of the WHO Certification Scheme
Fermer ce répertoireA. IMPORTING COUNTRIES
Afficher le documentBenin
Afficher le documentCameroon
Afficher le documentCentral African Republic
Afficher le documentEcuador
Afficher le documentFiji
Afficher le documentJamaica
Afficher le documentKenya
Afficher le documentMalawi
Afficher le documentMalaysia
Afficher le documentMyanmar
Afficher le documentPapua New Guinea
Afficher le documentSri Lanka
Afficher le documentTanzania
Afficher le documentTunisia
Afficher le documentYemen
Ouvrir ce répertoire et afficher son contenuB. EXPORTING COUNTRIES
Ouvrir ce répertoire et afficher son contenuC. INTERNATIONAL SUPPLY AGENCIES
Afficher le documentBACK COVER
 

Tunisia

1. Population

8.5 million in 1992.

2. Pharmaceutical import and consumption

Total imports of pharmaceuticals in 1992 were estimated to be US$ 112.79 million. Main exporting countries were: Bulgaria 1.5%, France 74%, Germany 1.5%, Italy 4%, Jordan 35%.

Drug consumption in 1992 in the public and private sector amounted to US$ 29 and US$ 131 million respectively. The total public sector drug budget for 1992 was US$ 27 million.

3. Drug policy and essential drugs list

The 8th Final Report of Health Plan of September 1991 reflects the national drug policy of the country. The policy covers all aspects relating to drug regulatory control, drug registration, drug procurement and quality assurance. There is a plan, developed in April 1993, for the implementation of the policy.

The National Essential Drugs List of Tunisia was formulated on 24 September 1991 and is used for procurement in the public sector. The list comprises 304 products.

4. Infrastructure and functioning

4.1 Drug regulation and registration

Law No. 85-91 of 22 November 1985 is used for the regulation of human drugs in Tunisia. Guidelines for registration of drugs were developed on 15 December 1990 but actual registration started in 1992. Decree No. 90.1400 of 3 September 1990 defines among other things, regulation of GMP and quality control, storage, labelling, nomenclature and promotion.

The Department of Pharmacy and Medicines is responsible for the development of legislation. The Division of Registration coordinates drug registration. All drugs imported into the country are subject to registration.

4.2 Public and private procurement

Pharmacie Centrale de Tunisie is the sole drug importing agency in the country. Procurement is done by means of open and restricted tender as well as through negotiation. In 1992, 450 products were purchased from manufacturers in France.

4.3 Quality control of drugs

Drugs are tested by the National Drug Quality Control Laboratory of Tunisia before authorization for marketing, to ensure conformity to open tender and in post-marketing surveillance. In 1992, 741 samples were sent for testing and 78% passed the tests. Samples are sent for testing after receipt and after payment and following complaints.

4.4 Inspection

The Division of Pharmacy Inspection under the Pharmacy and Medicines Department is responsible for the inspection of drug establishments.

 


5. Operation of the WHO Certification Scheme

Tunisia accepted the Scheme on 8 February 1978 and the responsible authority is the Direction de la Pharmacie des Laboratoires et des Médicaments de la Santé, Place Bab Saadoum, Tunisia. A copy of the marketing authorization from the country of origin, attestation of sale of the product in the country of origin and batch certificate are requested for registration and import of drugs into the country. Attestation of import authorization is sent to Customs officers and to the procurement agency to notify them on products registered in the country. A circular is made twice a week and official nomenclature of products authorized for importation is given to all pharmacists. Contact with competent authorities of exporting countries is made directly or through intermediaries.

Observations:

• A Certificate of a Pharmaceutical Product is not a prerequisite for drug registration.

• All drugs imported into the country are registered.

• Marketing authorization, attestation of sale of the product in the country of origin and batch certificate are required for registration and for importation of drugs.

• Quality assurance of marketed drugs is effective.

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